510(k) · Cleared
ClearedHem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex Medical · FZP Clip, Implantable
Cleared on Jul 3, 2025 as substantially equivalent to K232970 (Teleflex Medical, 2024) after a 90-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jul 3, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- FZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922186 (1992). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922186 Hem-O-Lok -- ModificationLinvatec Corp. · 1992
- 5 generations backK982941 Hem-O-Lok Model Numbers 523900, 523970Weck Closure Systems · 1998 · Recalled
- 4 generations backK993157 Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer…Weck Closure Systems · 1999 · Recalled
- 3 generations backK062914 Hem-O-Lok Ligation ClipTeleflex Medical · 2006
- 2 generations backK133202 Hem-O-Lok Ligating ClipTeleflex Medical · 2013
- 1 generation backK232970 Hem-o-lok® Ligating ClipsTeleflex Medical · 2024
- This deviceK251054 Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922186 | Hem-O-Lok -- Modification | Linvatec Corp. | 1992 | — |
| −5 | K982941 | Hem-O-Lok Model Numbers 523900, 523970 | Weck Closure Systems | 1998 | 1 |
| −4 | K993157 | Hem-O-Lok SMX Polymer Clips, Model 544220, Hem-0-Lok MLX Polymer Clips, Model… | Weck Closure Systems | 1999 | 1 |
| −3 | K062914 | Hem-O-Lok Ligation Clip | Teleflex Medical | 2006 | — |
| −2 | K133202 | Hem-O-Lok Ligating Clip | Teleflex Medical | 2013 | — |
| −1 | K232970 | Hem-o-lok® Ligating Clips | Teleflex Medical | 2024 | — |
| 0 (this device) | K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | Teleflex Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FZP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FZP device
- #1 K260677 Vessel Closure Device (VCD177213P)score 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232970 | Hem-o-lok® Ligating ClipsSummary page 6…ew Submission Primary Predicate Equivalence 510(k) Number K251054 K232970 N/A Hem-o-lok™ PurplePlus™ Large… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 5 of the 9 ancestors have a recall of any class.
How does its category compare?
All FZP devicesFZP Clip, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FZP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FZP
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FZP
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZP
1,902in 2025
MAUDE reports naming product code FZP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 31 | 1 | 1,877 |
| 2008 | 4 | 23 | 6 | 981 |
| 2009 | 3 | 22 | 0 | 2,160 |
| 2010 | 6 | 47 | 1 | 2,367 |
| 2011 | 3 | 124 | 0 | 1,678 |
| 2012 | 2 | — | 1 | 1,677 |
| 2013 | 3 | 47 | 0 | 2,381 |
| 2014 | 3 | 29 | 1 | 2,320 |
| 2015 | 8 | 182 | 0 | 2,871 |
| 2016 | 5 | 72 | 2 | 1,840 |
| 2017 | 4 | 29 | 1 | 2,594 |
| 2018 | 4 | 143 | 0 | 2,718 |
| 2019 | 1 | — | 3 | 2,903 |
| 2020 | 2 | — | 1 | 1,760 |
| 2021 | 0 | — | 0 | 1,759 |
| 2022 | 3 | 227 | 0 | 1,575 |
| 2023 | 3 | 65 | 0 | 1,918 |
| 2024 | 2 | — | 0 | 2,067 |
| 2025 | 5 | 90 | 0 | 1,902 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251054: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251054
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026